Exercise as Alcohol Use Disorders Intervention for Non-Treatment Seeking Adults

Alcohol-Related Disorders Clinical Trial

Official title:

Exercise as Alcohol Use Disorders Intervention for Non-Treatment Seeking Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399554
• Other study ID #: 1R03AA020194
• Secondary ID: 1R03AA020194
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2011
• Last updated: April 4, 2014
• Start date: April 2011
• Est. completion date: August 2013

Study information

• Verified date: April 2014
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Alcohol use disorders are common and few individuals with the disorder ever seek help. This study proposes to intervene in a novel way - exercise, as it has many mental and physical health benefits and is an activity that is incompatible with simultaneous alcohol use. If effective, this non-stigmatizing intervention may increase the utility and acceptability of interventions for alcohol use disorders and ultimately increase the number of individuals effectively treated.

Description:

About 26 million Americans (8.5%) meet criteria for an alcohol use disorder (AUD; i.e., abuse or dependence), and most with an AUD will not ever seek help. A variety of reasons exist for not seeking help, with stigma and desire to handle the problem on one's own being primary among them. Therefore, offering interventions for AUD that do not stigmatize or require an individual to see a mental health professional may increase the utility and acceptability of AUD interventions and ultimately increase the number of individuals effectively treated. This pilot study evaluates exercise as an AUD intervention. Exercise has been proposed as a potential treatment for AUD due to its numerous mental and physical health benefits. Thirty sedentary non-treatment seeking AUD individuals to be recruited from the community via advertisements. Participants will be given a four month YMCA gym membership and will be randomized to one of two conditions: (1) assessment only (AO), or (2) a combination of two motivational enhancement therapy (MET) sessions focused on increasing exercise spaced two months apart and four months of weekly contingency management (CM) for adhering to specific exercise activities. MET is a client-centered, directive method of enhancing intrinsic motivation to change by exploring and resolving ambivalence, and CM is a behavioral treatment offering individuals tangible reinforcers such as prizes for completion of specific target behaviors. Assessments of all participants will take place at baseline, 2-months (mid-treatment), and 4-months (post-treatment. Results from this pilot study will guide future investigations of exercise as a method for intervening with non-treatment seeking AUD individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age 21-55 years

• English speaking

• Sedentary

• Alcohol-related problems

• Recent heavy drinking episodes

• Blood pressure <165/95 mmHg

Exclusion Criteria:

• Currently receiving or desiring treatment for alcohol problems

• Contraindications for exercise

• Acute psychiatric problems that require immediate treatment

• Obese - class II

• Pregnant or desire to become so in the next several months

• Other substance dependence

• In recovery for pathological gambling

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol-Related Disorders

Intervention

Behavioral:
• Motivational Enhancement Therapy plus Contingency Management
A combination of two motivational enhancement therapy (MET) sessions focused on increasing exercise spaced two months apart and four months of weekly contingency management (CM) for adhering to specific exercise activities. MET is a client-centered, directive method of enhancing intrinsic motivation to change by exploring and resolving ambivalence, and CM is a behavioral treatment offering individuals tangible reinforcers such as prizes for completion of specific target behaviors.

Locations

Country	Name	City	State
United States	Saint Louis University	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
St. Louis University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monthly drinking frequency		Six months	No
Secondary	Monthly Exercise Behavior		Six months	No